Indian pharmaceutical giants, Glenmark and Dr. Reddy’s Laboratories, have been asked to recall drugs manufactured by them after they were found to have “failed impurities/degradation specifications”.
The US Food and Drug Administration (USFDA) said in its latest Enforcement Report that a US-based unit of Glenmark Pharmaceuticals is recalling 26,928 packs of oral contraceptive medication in the US, while New Jersey-based Dr. Reddy’s Laboratories Inc is recalling 571 vials of Succinylcholine Chloride Injection.
Both the drug firms issued a Class II recall, which is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal, as per the USFDA.
Also Read: Indian pharma majors recall drugs in US over manufacturing issues
Glenmark Pharmaceuticals Inc, USA, is recalling the affected lot of Viorele, Desogestrel and Ethinyl Estradiol (USP, 0.15 mg/ 0.02 mg) and Ethinyl Estradiol tablets due to “failed impurities/degradation specifications”. The affected lot was produced at the Mumbai-headquartered drug maker’s Goa manufacturing facility.
The drug firm issued the Class II nationwide recall on September 3, 2025.
Meanwhile, a US-based subsidiary of Dr. Reddy’s Laboratories is recalling the medication used to provide muscle relaxation during surgery – Succinylcholine Chloride Injection – due to “out-of-specification results during the 6-month stability testing”, USFDA stated.
The company initiated the Class II recall on September 26 this year.
India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.
Follow us
